Singapore - English - HSA (Health Sciences Authority)

sg medical imaging pte. ltd. - radiology / imaging - the dbis device is intended as an adjunct to mammogram for the diagnostic screening for detection of breast cancer. thermography devices should not be used for routine breast cancer screening or diagnosis, but may only be used as an adjunctive tool to mammography.

Australia - English - Department of Health (Therapeutic Goods Administration)

pentax medical singapore pte ltd - 60723 - medical image management system - to electronically receive, transfer, collect, store, and display a broad range of medical imaging/video data

Singapore - English - HSA (Health Sciences Authority)

medical imaging systems pte. ltd. - radiology / imaging - the platinum is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. using a digital flat detector, it can perform a range of applications including general rif, angiography and pediatric examinations. it is intended to visualize anatomical structures by converting a pattern of x-ray into a visible image. the system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract. may also be used in lymphography, endoscopy, myclography, venography, pediatrics, arthrography, interventional radiology, digital angiography and digital subtraction angiography (dsa). platinum may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations. platinum is intended to acquire tomographic images of human anatomy. tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep.

Singapore - English - HSA (Health Sciences Authority)

medical imaging systems pte. ltd. - radiology / imaging - the selenia™ full field digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer. the selenia™ full field digital mammographysystem is intended for use in the same clinical applications as traditional screen-film mammographic systems. mammographic images can be interpreted on either hard copy film or soft copy review workstation. the digital stereoloc ii is an optional accessory for the selenia full field digital mammography system. it is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from stereotactic pairs of two-dimensional images. it is intended to provide guidance for interventional purposes such as biopsy, presurgical locations, or treatment devices.

Singapore - English - HSA (Health Sciences Authority)

medical imaging systems pte. ltd. - radiology / imaging - the supersonic imagine aixplorer® ultrasound system is intended for general purpose pulse echo ultrasound imaging, doppler fluid flow analysis of the human body, and tissue elasticity imaging of soft tissues.

Singapore - English - HSA (Health Sciences Authority)

medical imaging systems pte. ltd. - radiology / imaging - the biovision digital specimen radiography (dsr) system is a cabinet digital x-ray imaging system intended to generate and control x-rays for examination of various anatomical regions, and to provide rapid verification that the correct tissue has been excised during excisional or percutaneous biopsy.

Singapore - English - HSA (Health Sciences Authority)

medical imaging systems pte. ltd. - radiology / imaging - non-invasive ablation of breast fibroadenoma. diagnosis of breast fibroadenoma must be confirmed by clinical examination, imaging and biopsy, in order to exclude phyllodes tumors or other types of tumors. non-invasive ablation of benign thyroid nodules. diagnosis of benign thyroid nodule must be confirmed by clinical examination and biopsy.

Singapore - English - HSA (Health Sciences Authority)

medical imaging systems pte. ltd. - radiology / imaging - sonovein is an ultrasound therapeutic medical device which is intended for the coagulation of blood vessels in patients with superficial vein reflux.

Australia - English - Department of Health (Therapeutic Goods Administration)

bk medical australia pty ltd - 60724 - medical image management system application software - mim symphony dx lite software is intended for trained medical professionals including, but not limited to, radiologists, oncologists, physicians and medical technologists. mim symphony dx lite software is a medical image and information management system that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, as well as create, display and print reports from those images. the medical modalities of these medical imaging systems include, but are not limited to, ct, mri, cr, dx, mg, us, spect, pet and xa as supported by acr/nema dicom 3.0. mim symphony dx lite software provides the user with the means to display, register and fuse medical images from multiple modalities. mim dx light software provides tools to quickly create, transform, and modify contours, transferring contours and archiving contours for patient follow- up and management.

Singapore - English - HSA (Health Sciences Authority)

medical imaging systems pte. ltd. - general & plastic surgery - the molli marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the molli marker can only be implanted for less than 30 days. using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (molli system), the molli marker is located and surgically removed with the target tissue. the molli system is intended only for the non-imaging detection and localization of the molli marker that has been implanted in a site intended for surgical removal.